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In this episode, Dan Bowyer, Lomax, and Mads Jensen reunite to talk about the stories behind the headlines - Trump's tariffs, EU's sluggish startup strategy, the Anthropic surge, and why Europe's hardware design hopes might rest on Munich.From missiles interrupting pool time in Tel Aviv to Nvidia's record-breaking quarter, the crew tackles everything from macro trade wars to micro founder incentives—plus a healthy dose of sarcasm, realpolitik, and startup survival.Here's what's covered:04:30 Tariffs, trade wars & what it means for European startups08:15 Harmonization vs. regulation: Why EU/US divergence matters10:55 Tariffs & inflation: Why macro still rules the game13:10 The public/private schism and bond market dismay21:45 The EU startup plan: blue carpets, unicorn labs & old ideas26:00 Talent, tax & the fight for Europe's future founders29:30 Why Munich might be Europe's next deep tech capital31:00 Big tech flexes: Google, Anthropic, and the return of hardware35:00 Vibe coding & SaaS disruption: The new normal?41:00 AI agents, Nvidia blowouts, and the pace of change45:20 Deal of the Week: Brightflag exits for $425M57:00 Why the crew skipped SuperVenture to actually build stuff
Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
In this episode, we chat about using multiple large scale neuroimaging datasets for developmental cognitive neuroscience research. We highlight two exciting recent projects, including the Reproducible Brain Charts database and a foundational study on white matter development. Along the way, we chat about harmonizing multiple datasets, testing in multiple datasets for generalizations, replicability, practical challenges, and more. Matt is joined by two wonderful guests from Dr. Ted Satterthwhaite's lab who are pioneering these momentous efforts - Dr. Golia Shafiei and Audrey LuoReach out to our host:Matt Mattoni (matt.mattoni@temple.edu)Connect with our guests:Dr. Golia Shafiei: https://bsky.app/profile/goliashf.bsky.socialAudrey Luo: https://bsky.app/profile/audreycluo.bsky.social Connect with us on social media! We are always looking for ideas for episode topics, co-hosts, or guests. @FluxSocietyKey Resources:Reproducible Brain ChartsTwo Axes of White Matter DevelopmentReproducibilibuddyhttps://reprobrainchart.github.io/
- ICYMI: Yesterday's post-presser commentary from Ashe & Gordon, while we wait for government to start - DOGE: Ways and Means Committee reviews resolutions on government access to finances, Social Security - President Trump welcomes Irish Prime Minister Michael Martin - CONTINUED: Ways and Means Committee reviews resolutions on government access to finances, Social Security - President Trump's Bilateral Meeting with the Taoiseach of Ireland, Irish PM Michael Martin - CONTINUED: Ways and Means Committee reviews resolutions on government access to finances, Social Security - President Trump, Speaker Mike Johnson, and Irish Prime Minister Michael Martin speak at the White House Luncheon - President Trump speaks at the Business Round Table (from 3.11.25) - Senate Commerce, Science, and Technology Committee on Subpoenas - Commentary from Ashe in America - House Subcommittee on Cybersecurity and Infrastructure Protection Hearing "Regularity Harm or Harmonization? Examining the Opportunity to Improve the Cyber Regulatory Regime" - House Foreign Affairs Africa Subcommittee: Conflict and Persecution in Nigeria
In this episode, I sit down with Stephen Smith, founder of the Center for Building, to uncover the labyrinthine world of building codes—how they're made, who really influences them, and why they end up stifling the very innovation and affordability we need. From the peculiarities of elevator requirements to the often overlooked role of local politics and special interests, we unpack how these complex rules shape our homes, buildings, and cities more than we might realize.TAKEAWAYSWhy Building Codes Matter: Even if you're not a builder or developer, codes dictate your home's layout, the price of housing, and whether your favorite small condo project can even get off the ground.The ICC (International Code Council) Isn't Really “International”: You'll learn how this non-governmental body, which writes most U.S. building codes, can be both extremely influential and surprisingly insular.Over-Regulation's Real-World Costs: We break down how elevator mandates, fire codes, and accessibility requirements—though well-intended—sometimes create perverse incentives that drive up costs or discourage better solutions.Local Politics & Hidden Interests: Discover how “government members” and private manufacturers shape these codes, and why your mayor or city council may have little say in regulations that affect everyone.A Path Forward: Stephen shares practical ways policymakers and citizens can get involved in reforming the system, focusing on a more human-centered approach that balances safety, cost, and beautyCHAPTERS00:00 The Challenge of Building Codes in the U.S.03:06 The Role of Building Codes in Urban Development05:46 Understanding the American Way of Building09:09 The Impact of Building Codes on Housing Costs12:09 Elevator Regulations and Their Consequences14:52 Harmonization of Codes and Standards18:11 Over-Dimensioning in American Construction21:05 Labor Issues in the Construction Industry23:57 The Need for Code Review and Justification26:49 The Tyranny of Bureaucracy in Building Codes38:49 The Grenfell Fire and Its Aftermath45:05 Design Innovations in Building Codes48:25 Understanding the ICC and Code Writing58:09 The Revolving Door: Industry and Regulation01:07:26 The Role of Government in Building Codes01:15:20 Getting Involved: Supporting Change in Building CodesCONNECT WITH STEPHENCenter for Building https://www.centerforbuilding.org/BlueSky: https://bsky.app/profile/stephenjacobsmith.com Email: stephen@centerforbuilding.orgMENTIONED RESOURCESElevator research: https://admin.centerforbuilding.org/wp-content/uploads/2024/12/Elevators.pdf CONNECT WITH AUSTIN TUNNELLNewsletter: https://playbook.buildingculture.com/https://www.instagram.com/austintunnell/https://www.linkedin.com/in/austin-tunnell-2a41894a/https://twitter.com/AustinTunnellCONNECT WITH BUILDING CULTUREhttps://www.buildingculture.com/https://www.instagram.com/buildingculture/https://twitter.com/build_culturehttps://www.facebook.com/BuildCulture/SPONSORSThank you so much to the sponsors of The Building Culture Podcast!Sierra Pacific Windows: https://www.sierrapacificwindows.com/One Source Windows: https://onesourcewindows.com/
Send us a textWelcome friend to this week's update! This week's themes:✨Harmonization & Empowerment ✨Befriending Fear✨Healing Wounds around not being supported ✨Resurrection of Old Dreams✨Rest & Celebration Enjoy! Support the showSubscribe to gain Eclusive Podcast Episodes!https://www.buzzsprout.com/1233209/subscribeSubscribe for Monthly Healing Sessions:(readings, reiki, and channeling)https://www.rebeccameisl.com/category/all-productsSubscribe to My YoutTube Channel@RebeccaMeislContact Rebecca Rebeccameisl.comRebecca.meisl@hotmail.comInstagram & Tik Tok - @rebeccameisl
This week Leonard Bailey, Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit for the Department of Justice (DOJ), Criminal Division, joins us this week. We dive into the role of the DOJ in addressing the vast and ever-changing landscape of cybersecurity. Bailey shares insights on partnering with federal agencies as well as the private sector, navigating information sharing pathways, evolution of incident and cyber threat reporting procedures, and the recent release of the Harmonization of Cyber Incident Reporting to the Federal Government. He also helps debunk information sharing myths and spotlights available tools and benefits of cyber threat information disclosure. Leonard Bailey The Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit and Special Counsel for National Security in the Department of Justice's (DOJ) Criminal Division. He has prosecuted computer crime cases and routinely advised on cybersecurity, searching and seizing electronic evidence, and conducting electronic surveillance. He has managed DOJ cyber-policy as Senior Counselor to the Assistant Attorney General for the National Security Division and then as an Associate Deputy Attorney General. He has also served as Special Counsel and Special Investigative Counsel for DOJ's Inspector General. Bailey is a graduate of Yale University and Yale Law School. He has taught law courses at Georgetown Law School and Columbus School of Law in Washington, DC. For links and resources discussed in this episode, please visit our show notes at https://www.forcepoint.com/govpodcast/e317
Accelerometer Harmonization Methods (Pt1) - ProPASS Webinar - Prof. Ulf Ekelund and Dr. Jakob Tarp Part 1. This is audio from ProPASS ECR network webinar. In the third webinar (2nd December) we will hear from Prof. Ulf Ekelund and Dr. Jakob Tarp on harmonization methods. Pooling individual participant data from several research projects may not always be feasible. This talk will cover examples of meta-analyses/data harmonizations performed without transfer of original data. --- The Prospective Physical Activity, Sitting and Sleep consortium (ProPASS) ProPASS is an international research collaboration platform of cohorts using thigh-worn accelerometry to explore the effects of physical activity, posture, and sleep patterns on a wide range of health outcomes. The objectives of the consortium are: to establish a pooled data resource on physical activity, posture allocation, sleep, and health outcomes. to develop methods for processing, harmonizing, and pooling data of existing such studies. to develop methods for collecting data for future studies (prospective harmonization). The ultimate goal of the ProPASS consortium as a data resource is to promote collaborative individual participant and prospective meta-analyses on physical activity, posture, and sleep. --- This podcast episode is sponsored by Fibion Inc. | Better Sleep, Sedentary Behaviour and Physical Activity Research with Less Hassle --- Collect, store and manage SB and PA data easily and remotely - Discover ground-breaking Fibion SENS --- Learn more about Fibion Flash - a versatile customizable tool with HRV and accelerometry capability. --- SB and PA measurements, analysis, and feedback made easy. Learn more about Fibion Research. --- Learn more about Fibion Sleep and Fibion Circadian Rhythm Solutions. --- Fibion Kids - Activity tracking designed for children. --- Explore our Wearables, Experience sampling method (ESM), Sleep, Heart rate variability (HRV), Sedentary Behavior and Physical Activity article collections for insights on related articles. --- Refer to our article "Physical Activity and Sedentary Behavior Measurements" for an exploration of active and sedentary lifestyle assessment methods. --- Learn about actigraphy in our guide: Exploring Actigraphy in Scientific Research: A Comprehensive Guide. --- Gain foundational ESM insights with "Introduction to Experience Sampling Method (ESM)" for a comprehensive overview. --- Explore accelerometer use in health research with our article "Measuring Physical Activity and Sedentary Behavior with Accelerometers ". --- For an introduction to the fundamental aspects of HRV, consider revisiting our Ultimate Guide to Heart Rate Variability. --- Follow the podcast on Twitter https://twitter.com/PA_Researcher Follow host Dr Olli Tikkanen on Twitter https://twitter.com/ollitikkanen Follow Fibion on Twitter https://twitter.com/fibion Check our YouTube channel: https://www.youtube.com/@PA_Researcher
Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space. 00:00 Introduction and Personal Insights 00:28 Defining Harmonization 02:38 Challenges in Regulatory Harmonization 03:43 Operational Harmony and Internal Collaboration 10:38 Sponsor and CXO Harmonization 14:15 Internal Drug and Device Harmonization 17:37 Solutions and Final Thoughts 20:41 Conclusion and Thank You ---------------------------------------- This talk was given at the PharmaED Resources Pre-filled Syringes & Injection Devices 2024 Conference: Exploring the Future of Parenteral Combination Products December 4-5, 2024, La Jolla, CA Note: Apologies for the audio not being of the quality you're used to —this is after hours of post-production. Trust me, the original was worse.
This interview was recorded for the GOTO Book Club.http://gotopia.tech/bookclubRead the full transcription of the interview here:https://gotopia.tech/episodes/323Gregor Hohpe - Author of "Platform Strategy", "The Software Architect Elevator", et al.James Lewis - Software Architect & Director at ThoughtworksRESOURCESGregorhttps://twitter.com/ghohpehttps://www.linkedin.com/in/ghohpehttps://architectelevator.comJameshttps://twitter.com/boicyhttps://linkedin.com/in/james-lewis-microserviceshttps://github.com/boicyhttps://www.bovon.orgDESCRIPTIONJames Lewis and Gregor Hohpe discuss the concept of dimensionality in decision-making, particularly in the context of innovation versus standardization. Hohpe emphasizes the importance of understanding and removing constraints to unlock new opportunities, citing historical shifts in technology and platform thinking as key examples.They explore how traditional one-dimensional views often limit progress and the challenges of adapting to new paradigms, especially in organizations. The discussion also touches on the role of architects in facilitating these shifts and the strategic focus needed for internal platforms to thrive in the face of evolving technologies.RECOMMENDED BOOKSGregor Hohpe • Platform Strategy • https://amzn.to/4cxfYdbGregor Hohpe • The Software Architect Elevator • https://amzn.to/3F6d2axGregor Hohpe • Cloud Strategy • https://amzn.to/3TOS3NvGregor Hohpe • Enterprise Integration Patterns, Vol 2 • https://amzn.to/3TNedQ3Gregor Hohpe & Bobby Woolf • Enterprise Integration Patterns • https://amzn.to/3DqII9lGregor Hohpe • 37 Things One Architect Knows About IT Transformation • https://amzn.to/3z8uhnwTwitterInstagramLinkedInFacebookLooking for a unique learning experience?Attend the next GOTO conference near you! Get your ticket: gotopia.techSUBSCRIBE TO OUR YOUTUBE CHANNEL - new videos posted daily!
Please join Madelina Light and me as we talk about ReActivating Your Heart's Infinite Potential to Create MIRACLES! . Join us to explore: -What are The Magical Gifts of The 2024/ 888 Lion's Gate - Galactic StarGate Portal, Available for All of Us Now? (Lion's Star Beings Team - Message) -How The Abundant Sirian Diamond Star Light (We are receiving Now) is Benefiting Us, and Our Multidimensional Personal & Collective Physical Ascension? (Sirian Star Beings Team - Message!) -How to Connect with These Energies, to TurboBoost YOUR Psychic Gifts, YOUR Light Body Brilliance & Open YOUR Prosperity Gates for the next 9 Years ahead (2024 to 2033)? ( Surprise Star Beings Team - Message!) -Madelina will do An 888 Lion's Gate Portal - Light Body Group Meditation & Activation - To Open Your Heart & Your AuraFields to A New Way of Creating Miracles in Any Area of Your Life, and Help Humanity, All Kingdoms & Mother Earth as Well! -PLUS, Join Us Live during the Q & A's - to Get Your Question Answered by Madelina & The Galactic Team - Receive A Personal Mini Reading & Light Body Activation for One Miracle You Would like to Create for Yourself, Your Loved One's, or for Mother Earth! Madelina is A Multidimensional BioEnergy Intuitive - A Divine Love/Light & Sound Frequencies Transmitter & Soul Connector, A Way Shower, A Star Seed, and An Earth Light Grids Keeper. As An Ancient Soul - Clairsentient, and Empath - She Telepathically receives Messages from the Body's BioEnergetic Systems, the Divine/Soul/Higher Self, Angels/ Archangels/ Ascended Masters, and The Benevolent Galactics & Spirit Guides. Madelina is A Certified Medical Intuitive & Arcturian Reiki Master, and A Gifted BioEnergy Healer. During Groups and Private Sessions, Madelina Tunes in & Scans The Group Energy, or Personal BioField, Sharing with You the Soulful insights that She Receives, Channeling Divine Golden Light & Uplifting Sounds for BioEnergy Unblocking, Clearing, Balancing & Harmonization, as well as Self Empowerment Tools. Madelina also, conduct various Meditations, Activations & Processes, Helping People Worldwide with Her Unique - Multidimensional BioEnergy Divine Light/Sound/Sacred Geometry Frequency Transmission Technique - That was Gifted to Madelina from Mid 2018, by Her Divine Soul/Higher Self & The Arcturian Galactic Team. Madelina Loves to Empower You To Realign with Your Unique Original Divine Soul Song - To Reawaken Your Inner Power, Purpose & Innate Psychic Gifts, and Uplift Your Spirit - To Enjoy Emotional Harmony & Loving Relationships - To Restore Your Healthy BioEnergetic Systems & Reactivate Your Innate Healing Abilities - So You could Live Your Best Life NOW, and THRIVE! Speaker Gifts: https://awakentohappinessnow.com Madelina's Offers: https://awakentohappinessnow.com/s35madelina/ #shefaliburns , #awakentohappinessnow, #healing, #energy, #transformation, #consciousness, #love, #consciousliving, #joy, #empowerment, #wellness, #spirituality, #spiritualawakening, #awareness, #madelinalight
On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor's degree in Bioengineering from the University of California, Berkeley, his doctorate and master's degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.
Cassidy on the Gram and now Cassidy in the AW Studio! This woman can do it all! Encouraging and embracing all things women – whether that's in the office, in sneakers and giiiirl even in the club. She's a cool mom, with cool style, and a cool *couple, few, many* jobs. Tune in to this episode, Whiners, you're gonna love!Buy your tickets: Adultish Whines Live Podcast Follow the Pod: instagram.com/adultishwhines/Follow your Host: instagram.com/paige_crutcher/Follow Cassidy: instagram.com/cassidyonthegram/Follow Cassidy on LinkedIn for the Corporate Baddies + Side Hustlers Cassidy's unfiltered HR newsletter: yo-youre-on-mute.beehiiv.com/ Go to https://betterhelp.com/adultish for 10% off your first month of therapy with BetterHelp and get matched with a therapist who will listen and help #sponsoredUse code ADULTISH at adameve.com for 50% off, free gifts and free shipping.Use code AWCLUB at kingsofneon.com for 10% off a custom neon sign.
Teams are the new focal point of organizational design and organizational function. Motivation - quantified as “energy” by Proijal Ghatak and Onloop - is the key to team performance. Technology is advancing to the point where motivation can be monitored using AI, and self-reported feedback and other nuanced approaches to understanding and improving motivation levels are delivering real progress. Purpose portfolios can align individual motivations with organizational goals, capturing the role of purpose in driving productivity and engagement.Projjal mentioned companies experimenting with holocracy and distributed flat organizations, although scaling such structures was noted as challenging due to inherent human tendencies to seek direction and guidance. The conversation also explored frameworks like RAPID (Bain's Responsible, Accountable, Perform, Informed, Decide model) and spans of control, highlighting strategies for optimizing organizational effectiveness and managerial efficiency.Projjal emphasized the importance of respect and trust in leadership dynamics, noting that effective leaders inspire motivation and engagement through their actions and guidance. The role of AI in augmenting managerial capabilities and increasing spans of control was also discussed, highlighting the potential for technology to enhance organizational structures and improve managerial effectiveness.Resources: The Post-Managerial Era (Blog Post) Connect with Hunter Hastings on LinkedIn Connect with Projjal Ghatak on LinkedInonloop.comShow Notes:0:00 | Intro0:57 | Problem to Solve3:02 | Collaborative Software Tools Shift Mindsets9:31 | Great Breakthrough: Products Addressing Management Problems16:44 | HR's Original Design: Suppressing Dissent, Keeping Control17:44 | Teams as Core Units: Hybrid, Remote and Onsite21:41 | Entrepreneurial Intent Without Clear Goals25:11 | Feedback Loop26:19 | New Performance Management Project 31:25 | How Do Projjal Detect Motivation?35:29 | Experimenting with 'Things That Matter'38:15 | Service Orientation41:04 | Organization and Firm Structure50:40 | Right Hemisphere Dominant VS Left Hemisphere Dominant 53:19 | Wrap-Up
Welcome to the Hughes Hubbard Anti-Corruption & Internal Investigations Practice Group's podcast All Things Investigation. In this podcast, Tom Fox is joined by Jan Dunin-Wasowicz a partner at Hughes Hubbard & Reed, who is a leading figure in trade sanctions and Jeff Nielsen, International Sanctions & Export Controls Lawyer at Rambol, for a deep dive into current issues in export control and economic sanctions. In Part 2 of a special two-part series on All Things Investigations, host Tom Fox is once again joined by Jeff Nielsen and Jan Dunin-Wasowicz to discuss trade sanctions from a global perspective. In this Part 2, Jeff and Jan provide their expertise on the EU Directive on Harmonization of Criminal Sanctions, detailing its implications and the challenges faced in its implementation across the 27 member states. They explain the mechanics of EU sanctions, enforcement disparities among member states, and the directive's focus on setting minimum standards for criminal offenses. The conversation also delves into future outlooks on the EU's stance towards the Russian invasion of Ukraine and the evolving profession of trade sanctions compliance. Key Highlights: Understanding the EU Directive on Harmonization of Criminal Sanctions Challenges and Implications of the Directive Future of Trade Sanctions and Compliance Career Advice for Aspiring Trade Sanction Experts Conclusion and Final Thoughts Resources: Hughes Hubbard & Reed website Jeff Nielsen on LinkedIn Jan Dunin-Wasowicz on LinkedIn HHR client alert on The Dawn of a New Era for EU Sanctions Enforcement? EU Adopts Directive on the Definition of Criminal Offences and Penalties for the Violation of EU Sanctions
Contaminated Site Clean-Up Information (CLU-IN): Internet Seminar Video Archives
To help meet the U.S. Environmental Protection Agency (EPA) Superfund program's mandate to protect human health and the environment from current and potential threats posed by uncontrolled hazardous substance (both radiological and non-radiological), pollutant, or contaminant releases, the Superfund program has developed a human health evaluation process as part of its remedial response program. The process of gathering and assessing human health risk information is adapted from well-established chemical risk assessment principles and procedures. Within the Superfund remediation framework, radioactive contamination is dealt with in a consistent manner as with chemical contamination, except to account for the technical differences between radionuclides and chemicals. This consistency is important since at every radioactively contaminated site being addressed under Superfund's primary program for long-term cleanup, the National Priorities List (NPL), chemical contamination is also present. To view this archive online or download the slides associated with this seminar, please visit http://www.clu-in.org/conf/tio/remedial-radrisk_052224/
Contaminated Site Clean-Up Information (CLU-IN): Internet Seminar Audio Archives
To help meet the U.S. Environmental Protection Agency (EPA) Superfund program's mandate to protect human health and the environment from current and potential threats posed by uncontrolled hazardous substance (both radiological and non-radiological), pollutant, or contaminant releases, the Superfund program has developed a human health evaluation process as part of its remedial response program. The process of gathering and assessing human health risk information is adapted from well-established chemical risk assessment principles and procedures. Within the Superfund remediation framework, radioactive contamination is dealt with in a consistent manner as with chemical contamination, except to account for the technical differences between radionuclides and chemicals. This consistency is important since at every radioactively contaminated site being addressed under Superfund's primary program for long-term cleanup, the National Priorities List (NPL), chemical contamination is also present. To view this archive online or download the slides associated with this seminar, please visit http://www.clu-in.org/conf/tio/remedial-radrisk_052224/
Will there be a future return to animal sacrifices when Christ returns? If that's what the Bible says, how would such a position reconcile with the all-sufficient sacrifice of Jesus on the cross? Peter looks deeply into these questions by analyzing a chapter from Matt Waymeyer on how one can reconcile a future temple and return to sacrifices with the book of Hebrews. Time Stamps: 00:00 Introduction to Importance of Topic 06:29 Texts Dealing with a Future Temple 11:40 Different Views on Future Sacrifices 13:26 View 1: Symbolic View 20:30 View 2: Memorial View 26:33 View 3: Ceremonial Cleansing View 31:51 The Nature of Atonement in Ezekiel 40-48 37:37 The Sacrificial System in the OT and Ezekiel 41:47 Harmonization with Hebrews 9-10 44:37 The Absence of the Day of Atonement in Ezekiel 47:35 The Broad Language of Hebrews 50:42 Paul's Example in Acts 21 59:15 Outro Article referenced on the prophetic expectation for a future temple: https://petergoeman.com/does-the-bible-say-there-will-be-a-future-temple-in-israel/ Book Referenced in Episode in Honor of Larry Pettegrew: https://www.amazon.com/dp/1959454005 Amillennialism and the Age to Come (Matt Waymeyer): https://www.amazon.com/dp/1934952257/ Matt Waymeyer on Revelation 20: https://www.youtube.com/watch?v=YylmWRfjqJU If you have found the podcast helpful, consider leaving a review on Itunes or rating it on Spotify. You can also find The Bible Sojourner on Youtube. Consider passing any episodes you have found helpful to a friend. Visit petergoeman.com for more information on the podcast or blog. Visit shepherds.edu for more on Shepherds Theological Seminary where Dr. Goeman teaches.
Will there be a future return to animal sacrifices when Christ returns? If that's what the Bible says, how would such a position reconcile with the all-sufficient sacrifice of Jesus on the cross? Peter looks deeply into these questions by analyzing a chapter from Matt Waymeyer on how one can reconcile a future temple and return to sacrifices with the book of Hebrews. Time Stamps: 00:00 Introduction to Importance of Topic 06:29 Texts Dealing with a Future Temple 11:40 Different Views on Future Sacrifices 13:26 View 1: Symbolic View 20:30 View 2: Memorial View 26:33 View 3: Ceremonial Cleansing View 31:51 The Nature of Atonement in Ezekiel 40-48 37:37 The Sacrificial System in the OT and Ezekiel 41:47 Harmonization with Hebrews 9-10 44:37 The Absence of the Day of Atonement in Ezekiel 47:35 The Broad Language of Hebrews 50:42 Paul's Example in Acts 21 59:15 Outro Article referenced on the prophetic expectation for a future temple: https://petergoeman.com/does-the-bible-say-there-will-be-a-future-temple-in-israel/ Book Referenced in Episode in Honor of Larry Pettegrew: https://www.amazon.com/dp/1959454005 Amillennialism and the Age to Come (Matt Waymeyer): https://www.amazon.com/dp/1934952257/ Matt Waymeyer on Revelation 20: https://www.youtube.com/watch?v=YylmWRfjqJU If you have found the podcast helpful, consider leaving a review on Itunes or rating it on Spotify. You can also find The Bible Sojourner on Youtube. Consider passing any episodes you have found helpful to a friend. Visit petergoeman.com for more information on the podcast or blog. Visit shepherds.edu for more on Shepherds Theological Seminary where Dr. Goeman teaches.
Digital Stratosphere: Digital Transformation, ERP, HCM, and CRM Implementation Best Practices
Many organizations going through digital transformations do so because they want to harmonize the systems that they have. But what exactly is system harmonization and what can we do to achieve that? That's what I will be discussing today. #digitalstrategy #digitaltransformation #interoperability ORDER MY NEW BOOK: The Final Countdown: https://thefinalcountdown.com/
In this episode we will be chatting about :- DNA activation and cosmic consciousness, - Shifts in human capabilities and awareness- New sequences of DNA work- Genetic blueprints - Identity across different timelines- The higher self, galactic self and God self - The concept of sound and its role in organizing matter and consciousnessInfinite love ~ Sonia GLet's stay connected!Instagram : @moonbabesandthelighttribeWebsite : www.moonbabetribe.com
For a company that has been around since 1911, Mars has a reputation as one of the most visionary companies in the industry, particularly when it comes to building global capabilities that scale and flex to serve the needs of the regional lines of business. It's not any easy feat. Celia Van Wickel, Director Omnichannel Digital Commerce Analytics at Mars, drives building out their global digital commerce analytics strategy, and works closely with the business to design, test and scale capabilities that deliver efficiency, measure results, and identify opportunities for growth. She kindly agreed to join the podcast to share the art and science for enabling digital commerce analytics to every region around the world.
In the Gospels, we get four resurrection narratives. At first glance, there seems to be some dissonance and even contradictions between these four accounts. Let's dive in and see how beautifully the gospels harmonize to tell the most amazing event in all of history!
Sponsor: Medboard EU EU proposal to prevent shortage - And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey - Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf Spain: AEMPS consultation - Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/ EURL Second Call - More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en TEAM-NB Position Paper - Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/02/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf EMDN Proposal - Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/ MDCG 2024-2 : https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf Training Training Green Belt EU MDR - Learn by practicing: https://school.easymedicaldevice.com/course/gb30 Open March 25th, 2024 until March 29th, 2024TEAM-NB Training - Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdfApril 29th, 2024 Services Packaging and IFU - Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/ ROW USA Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device CANADA Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html Draft Guidance: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html Mexico Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es Saudi Arabia SFDA Harmonized Standards - Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf Qatar Qatar Telemedicine - Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf Australia TGA SOPP requirements - System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf TGA Essential Principles - Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls: https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf PODCAST Episode 271 - How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/ Episode 272 - Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/ Episode 272 - New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/ EASY MEDICAL DEVICE Services: Training: https://school.easymedicaldevice.com/emd-course/ Authorized Representative EU: https://easymedicaldevice.com/eu-rep/ Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/ Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/ Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/ Eqms SmartEye; https://smart-eye.io Conferences: https://medtechconf.com/
The Great Taking : Uncovering Economic Manipulation with Peak Prosperity Part 1 of 4. The global economic system is being manipulated by hidden individuals and institutions, leading to a concentration of wealth and power, intentional induced financial crises, and the dematerialization of securities, and that this system must be dismantled non-violently. It's important because it answers the question, “How exactly will I end up owning nothing as the WEF has prognosticated?” If you'd rather not lose all your wealth to a bunch of amoral Wall Street crooks in a legalized transfer of wealth, then this series is for you. Watch this presentation at- https://youtu.be/O3pq0WURDW8?si=prX2zdDTcEX-fn1L Peak Prosperity 512K subscribers 14,019 views Premiered 2/16/2024 #podcast #stockmarket #economy Join the Conversation (and download the audio book) here (Free): https://peak-prosperity.com/GrtTaking... Continuation to Part 1 found here: https://peak-prosperity.com/GTContinued Original David Webb interview that kicked this research off found here:: Part 1 (Free): https://peak-prosperity.com/DWEBB Part 2 (Free): https://peak-prosperity.com/DWEBBprt2 For more information on our amazing new webinar series - Prospering With Integrity with Bret Weinstein, Ed Dowd and Peter St Onge, click here: https://peak-prosperity.com/PWI4
In this podcast, host Steve Farrell is joined by pioneers in sound healing, collaborators, and dear friends of Humanity's Team Jonathan & Andi Goldman, for an incredible collective and soul-cleansing 22nd annual World Sound Healing Day. During this discussion with Jonathan and Andi, you will learn of the sounds made to send love, compassion, and understanding to the Gaia Matrix and how the power of sound healing will lead our Global Collective to a higher state of consciousness. In this podcast, you will discover… The way sound fosters harmony on the planet The origin of World Sound Healing Day What the concept of seperated self is The effects of sound healing and intention How to listen without judgement and with compassion And much, much more… ***Note: this is a special rebroadcast, and any websites, links, programs, or events mentioned may no longer be active (or dates may have been changed). Thank you!*** For more teachings and rich healing experiences with The Goldmans, be sure to check out Humanity Stream+ here, where you will find dozens of great programs with them Explore Humanity's Team and the timeless truth that We Are All One. Learn more about the Humanity's Team free education programs.
This week Leonard Bailey, Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit for the Department of Justice (DOJ), Criminal Division, joins us this week. We dive into the role of the DOJ in addressing the vast and ever-changing landscape of cybersecurity. Bailey shares insights on partnering with federal agencies as well as the private sector, navigating information sharing pathways, evolution of incident and cyber threat reporting procedures, and the recent release of the Harmonization of Cyber Incident Reporting to the Federal Government. He also helps debunk information sharing myths and spotlights available tools and benefits of cyber threat information disclosure. Leonard Bailey The Head of Computer Crime and Intellectual Property Section's (CCIPS) Cybersecurity Unit and Special Counsel for National Security in the Department of Justice's (DOJ) Criminal Division. He has prosecuted computer crime cases and routinely advised on cybersecurity, searching and seizing electronic evidence, and conducting electronic surveillance. He has managed DOJ cyber-policy as Senior Counselor to the Assistant Attorney General for the National Security Division and then as an Associate Deputy Attorney General. He has also served as Special Counsel and Special Investigative Counsel for DOJ's Inspector General. Bailey is a graduate of Yale University and Yale Law School. He has taught law courses at Georgetown Law School and Columbus School of Law in Washington, DC. For links and resources discussed in this episode, please visit our show notes at https://www.forcepoint.com/govpodcast/e267
s we leave an exciting 2023, it's time to enter a new year. Without a doubt, the sustainability sector is witnessing transformative trends and predictions reshaping how businesses operate and consumers engage. This week, we discuss our thoughts as we enter 2024 and provide an in-depth look at these key trends and predictions our team has complied: Global supply chains under the microscope–The focus on transparency and public reporting within global supply chains has become more pronounced. This year, we're seeing a significant shift towards improving data accessibility, with large corporations and smaller suppliers under increased scrutiny. The emphasis is on creating a transparent supply network where every participant is accountable for their sustainability practices.The rise of technological integration–Integrating digital tools is set to revolutionize sustainability practices in supply chains and beyond. Developers and industry leaders expect these technologies to streamline processes, enhance transparency, and deliver comprehensive insights into supply chain operations.Regulatory changes driving action–Anticipated regulatory changes, especially from bodies like the Securities and Exchange Commission (SEC), push organizations to rethink and readjust their sustainability strategies. Companies are gearing up for new requirements, like calculating scope three emissions and preparing for third-party audits, signaling a shift towards more rigorous sustainability compliance.Harmonization in reporting standards–Industry leaders are actively aligning various sustainability reporting standards, like the SBTI and CSRD, to simplify compliance processes. This harmonization effort targets making it easier for organizations, especially those with limited resources, to meet sustainability reporting requirements. This trend is driving a more unified and coherent approach to sustainability reporting.Private equity's growing influence–The influence of private equity in shaping sustainability practices is becoming increasingly apparent–initiatives like the ESG Data Convergence guide firms towards more standardized reporting and actionable sustainability measures. This trend reflects the growing role of private equity in promoting sustainable practices among portfolio companies.Sustainability conversations in the boardroom–Environmental, Social, and Governance (ESG) topics are now taking center stage in corporate boardroom discussions. There is a heightened focus on genuine decarbonization efforts, avoiding greenwashing, and ensuring that concrete actions back public sustainability claims. This shift underscores the growing importance of sustainability in corporate governance and strategic decision-making. It will be interesting to look back a year from now and see how this year's predictions pan out. Many of these trends highlight a dynamic and evolving landscape in the sustainability sector for 2024, marked by increased accountability, technological advancement, regulatory alignment, and strategic corporate focus on genuine sustainability practices.
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance.Quotes"We're seeing pushes into adaptive algorithms... algorithms that modify themselves in the field without human oversight." - Eric Henry"The FDA and other regulators are no stranger to the issues in generative AI as well." - Eric Henry"Keep an eye on the FTC... they have a tool called algorithmic discouragement, which can have significant implications for AI in life sciences." - Eric HenryTakeawaysFTC's Growing Role: The FTC may soon have broader enforcement authority over AI across various industries in the U.S.Algorithmic Discouragement: A tool that allows the FTC to force companies to delete an algorithm and all its associated training data.Evolving Regulatory Landscape: The FDA is adapting its regulatory framework to accommodate AI, focusing on adaptive and generative AI.Challenges with Locked Algorithms: Current regulatory frameworks primarily support locked algorithms, but there's a movement towards adaptive algorithms.Impact of AI on Quality Systems: AI is set to revolutionize quality management systems and manufacturing processes in the life sciences.Importance of Pre-Market and Post-Market Oversight: Both are crucial for ensuring the safety and efficacy of AI-driven medical devices.The Role of CSA in AI Integration: The transition from CSV to CSA could influence how AI is integrated into software systems.Harmonization of Standards: A significant challenge in AI regulation is the harmonization of numerous standards being developed globally.Public-Private Partnerships: Collaborations like the AI Global Health Initiative are vital for advancing regulatory frameworks in AI.The Need for Industry Engagement: Active involvement in AI-focused organizations can help businesses navigate the evolving regulatory landscape.ReferencesVisit www.greenlight.guru for insights on streamlining product development in Medtech.Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance.Explore the AI Global Health Initiative under AFDO and RAPS sponsorship.For questions or consultations, contact Eric Henry at ehenry@kslaw.comVisit Greenlight Guru to learn more how to prepare your QMS for the future of MedTech.Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback.
A Harmonization of the Christmas Gospels
Artificial intelligence holds the promise of revolutionizing disease diagnosis and prediction, but it also presents a pivotal challenge: ensuring equity. In this Q&A, Alondra Nelson, PhD, the Harold F. Linder Professor at the Institute for Advanced Study, joins JAMA's Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, to discuss the equitable regulation of AI to benefit all populations. Related Content: How Do Policymakers Regulate AI and Accommodate Innovation in Research and Medicine?
“Platforms harmonize and standardize without restricting. By standardizing, they actually enable and allow people to do more things." Gregor Hohpe is back again for the second episode with his latest book “Platform Strategy”. In this episode, Gregor discussed in-depth about building platforms with a proper platform strategy. He began by describing what a platform is from a few different perspectives, the benefits it brings, and what strategy we should think about when building a platform. Gregor also emphasized the opposite difference between platforms and IT services, with the key difference of how a platform thrives with more scale. We then had a few fun discussions discussing building a platform on top of a cloud platform, the key skillset we need to build a good platform, and how we should build a proper platform abstraction. Towards the end, Gregor also covered the recent trend of building developer platforms and business capability platforms. Also, do not miss Gregor's fun analogy of fruit basket vs fruit salad when explaining a good platform strategy. Listen out for: Strategy Book Series - [00:05:39] Definition of Platform - [00:07:58] Platform Benefits - [00:12:09] Platform Strategy - [00:17:25] Platform vs IT Service - [00:20:47] Platform Thrives With Scale - [00:25:39] Cloud Platform-Based Platform - [00:29:36] Skillset for Building Platform - [00:36:44] Abstraction, Not an Illusion - [00:44:19] Fruit Salad vs Fruit Basket - [00:47:32] Developer Platform - [00:51:34] Business Capability Platform - [00:55:48] 3 Tech Lead Wisdom - [00:59:31] _____ Gregor Hohpe's BioGregor Hohpe advises CTOs and senior IT executives on IT strategy, cloud architecture, and organizational transformation. He served as advisor to the Singapore government, chief architect at Allianz SE, and technical director at Google Cloud's CTO Office. He is widely known as co-author of the seminal book “Enterprise Integration Patterns” and as frequent speaker at conferences around the world. His accessible, but technically accurate essays were republished in “97 Things Every Software Architect Should Know” and “Best Software Writing”. He is an active member of the IEEE Software editorial advisory board. Follow Gregor: Website – https://architectelevator.com/ LinkedIn – linkedin.com/in/ghohpe/ X – @ghohpe Platform Strategy (with special coupon for TLJ listeners) – https://leanpub.com/platformstrategy/c/techlead _____ Our Sponsors Are you looking for a new cool swag? Tech Lead Journal now offers you some swags that you can purchase online. These swags are printed on-demand based on your preference, and will be delivered safely to you all over the world where shipping is available. Check out all the cool swags available by visiting techleadjournal.dev/shop. And don't forget to brag yourself once you receive any of those swags. Like this episode? Show notes & transcript: techleadjournal.dev/episodes/156 Follow @techleadjournal on LinkedIn, Twitter, and Instagram. Buy me a coffee or become a patron.
Do you want to live a blissfully balanced life?In this episode of the Happy Hustle Podcast, I'm diving into the nitty-gritty of the systematic harmonization of ambition and well-being – what we like to call the Happy Hustle. Let's start with the basics. What is the Happy Hustle? It's all about persevering past adversity with a smile, symbolized by our cute logo with the X over the eye. But what intrigued people was the 'Happy Hustle' part. So, I dug deep and defined it as the systematic harmonization of ambition and well-being.Systematic means the execution of a fixed plan or system methodically. So, to achieve the harmonization, you need a methodical plan. It's not just a feel-good theory; it's a tangible roadmap. Because, let's face it, balance equals happiness. Now, ambition – it's that strong desire to achieve something, requiring determination and hard work. That's the hustle part. Well-being, on the other hand, is the state of being comfortable, healthy, and happy. Combine the two, and you've got the systematic harmonization of ambition and well-being – And that's the essence of the Happy Hustle.You might ask, how to make this systematic harmonization happen? It's the S.O.U.L.M.A.P.P.I.N Framework. This unique and proprietary system consists of 10 key areas of life that you need to focus on to achieve blissful balance, both personally and professionally.S.O.U.L.M.A.P.P.I.N breaks down into 10 key areas of life, forming the acronym itself:Selfless service – give your time, money, and efforts to causes you believe in.Optimized health – mentally, physically, emotionally optimized for peak performance.Unplug digitally – create intentional barriers in our hyper-connected world.Loving relationships – give yourself fully to family, friends, and your partner.Mindful spirituality – connect to something higher, whatever that means for you.Abundance financially – save, spend, and invest wisely for ultimate freedom.Personal development – grow and evolve every day, don't shrink and dissolve.Passionate hobbies – do things that bring you joy and create space for yourself.Impactful work – infuse your passion and purpose into your career.Nature connection – get outside, connect with the planet, and protect it.So that's the Happy Hustle, a blueprint for systematically harmonizing ambition and well-being. Whether you're a seasoned hustler or just starting out, this approach will transform your life.If you want to dive even deeper into this transformational journey, check out my book, The Happy Hustle 2.0. It's packed with scientific research, frameworks, acronyms, and happy hustle hacks. Pre-order now and get $350 worth of bonuses at thehappyhustle.com/book.Connect with Cary!https://www.instagram.com/cary__jack/https://www.facebook.com/SirCaryJackhttps://www.linkedin.com/in/cary-jack-kendzior/https://twitter.com/thehappyhustlehttps://www.youtube.com/channel/UCFDNsD59tLxv2JfEuSsNMOQ/featuredGet a free copy of his new book, The Happy Hustle, 10 Alignments to Avoid Burnout & Achieve Blissful Balance https://www.thehappyhustle.com/bookSign up for The Journey: 10 Days To Become a Happy Hustler Online Course http://www.thehappyhustle.com/JourneyApply to the Montana Mastermind Epic Camping Adventure https://caryjack.com/montana“It's time to Happy Hustle, a blissfully balanced life you love, full of passion, purpose, and positive impact!” Episode sponsor BIOptimizers Magnesium BreakthroughThis stuff is a game-changer! Magnesium Breakthrough packs all 7 forms of magnesium, designed to support stress management, promote muscle relaxation, regulate the nervous system, control stress hormones, boost brain function, increase energy, and enhance sleep.I take 2 capsules before bedtime, and it's been a game-changer for me. The best part is, BIOptimizers offer a risk-free 365-day money-back guarantee. No results, no problem – they'll refund you, no questions asked. It's a win-win!Head over to magnesiumbreakthrough.com/hustle and use code "hustle" for an exclusive 10% discount on any order. Plus, for a limited time, you'll score some special gifts with your purchase.BELAY Solutions (https://resources.belaysolutions.com/happyhustle?utm_campaign=The%20Happy%20Hustle&utm_source=email&utm_medium=Email%20Newsletter%20-%20D2E&utm_content=HH%20Native%20Ad%201)BELAY is a flexible staffing solution that helps busy leaders find the right help. 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Show Notes and Transcript Robert Malone's Substack has become essential reading for many of us. Every day nuggets of wisdom and insight, information and humour drop into inboxes all over the world. One of the recent emails caught our eye. What is Woke? It's a word that we have come familiar with but many of us would struggle to define it. It is an intolerant ideology that is sowing seeds of confusion and division. Robert returns once again to Hearts of Oak to discuss what sparked the article and we have a close look at 15 examples of wokeness that he has referenced before we touch on another of his Substacks about 'Adulteration', which is a topic that we hope to come back to in more detail soon. Robert W Malone MD, MS Inventor of mRNA & DNA vaccines, RNA as a drug. Scientist, physician, writer, podcaster, commentator and advocate. Believer in our fundamental freedom of free speech. Connect with Dr Malone..... GETTR: https://gettr.com/user/rwmalonemd X: https://twitter.com/RWMaloneMD?s=20 WEBSITE: https://www.rwmalonemd.com/ https://maloneinstitute.org/ SUBSTACK: https://rwmalonemd.substack.com/ Interview recorded 26.10.23 *Special thanks to Bosch Fawstin for recording our intro/outro on this podcast. Check out his art https://theboschfawstinstore.blogspot.com/ and follow him on GETTR https://gettr.com/user/BoschFawstin and Twitter https://twitter.com/TheBoschFawstin?s=20 To sign up for our weekly email, find our social media, podcasts, video, livestreaming platforms and more... https://heartsofoak.org/connect/ Support Hearts of Oak by purchasing one of our fancy T-Shirts.... https://heartsofoak.org/shop/ Transcript (Hearts of Oak) Robert W. Malone, MD. It is wonderful to have you back. Thanks so much for joining us today, Robert. (Robert Malone MD) Peter, thanks for your friendship. It's been a pleasure to host you on the farm a couple of times and all of our many podcasts. I don't know how many we're up to right now, but I always enjoy talking to you and through your to your audience. So thanks for having me on again. No, thank you. And if what you're doing doesn't work out, if everyone deserts you on Substack, then I think you do have another future, which is steaks. I think that was the best steak I've had outside Texas. So I say, open up a steak restaurant, Robert. Yeah, that might be my future if the powers that be have their way with me. If you say too much, because that's just safer. But just for the viewers, @rwmallonemd on Twitter, on GETTR, anywhere else, And of course, Substack, rwmalonemd.substack.com. You just type in Substack, Robert Malone will come up. All the links are in the description. And that is also a way to support what Robert does in the many places he travels, speaks, interviews, and all of that. That is a one way of supporting him. or getting his book, which I had beside me, Lies My Government Told Me. There it is, Lies My Government Told Me. Make sure if you haven't got a copy of that, get a copy, it's a great Christmas present. About to come out in Norwegian for all of your Norwegian listeners and in Dutch. I think we're gonna have the book launch in Norway in early December and the book launch in the Netherlands sometime in February. So stay tuned for that. And then we have another book that is just nearing completion on Cy-War and Sovereignty, which is the big propaganda, you know, there in the UK, you're certainly familiar with nudge technology and the 77th Brigade and MI6 and all of their various nefarious activities through the COVID crisis. Oh, yeah. I look forward to that coming out. The Norwegian languages, maybe I'll give it a miss. So I'll wait for the new book. We've got a great cover. I look forward to it. Robert, I love your Substack. There may be four different sub-stacks that I follow because you can have an avalanche of information and yours is one of those. And my favorite thing is you don't know what you're going to get. Each day is different. It could be on the farm, it could be travel, it could be latest scientific research coming out, it could be government agencies and how they work. And I love that huge mix and that wide array. And one of the recent ones just days ago was, what is woke and intolerant and moralizing ideology? And you had a little cartoon at the beginning and at the end, the definition was stuff I don't like, which I actually thought was a good definition. But it's a term that I think we now use frequently and we kind of know how to describe things as woke, but we're not very sure what exactly that is. If we see something, oh, that's woke, why? The definition of pornography, I can't define it but I know it when I see it. Same with woke. And yeah, so thanks. This was almost kind of a throwaway Substack, that Jill put together on the fly. Basically, we tend to wake up in the morning or as we're going to sleep the night before. This is our lives. Hey, welcome to our lives. We lay in bed and talk between the two of us. Well, when are we gonna write tomorrow? I don't know. Good heavens. And so, in this case, what transpired was we, when we like to turn off our brains, we turn to the, you know, streaming. We never watch television per se, but we stream. And they tend to fall into two categories, basically, science fiction and documentaries about history or travel. That's kind of our lives. I know it's pretty exciting. And so we were watching this new Netflix series called Bodies. And it proceeds because it's a kind of a multi-timeline thing that is all wrapped around the UK and London is the setting for the series. And I don't want to go into the plot line, but basically, in episode three, suddenly we have the insertion of this gratuitous, let's say, gently man love, with a fairly explicit scenery associated with it. And it was absolutely gratuitous, not necessary for the plot line. It was clearly another woke agenda insertion, as we have come to expect from Netflix routinely. And this one was so in your face that we just, both of us, looked at each other and flipped off the TV. Okay, enough of that. Time to go to bed. And then Jill, in the morning, woke up and she said, I've got to find some way to be able to pre-screen, these various streaming broadcasts for their woke content. I wonder if there's anything out there on the internet. And so she started searching, and she found this delicious site that is mentioned in the article. Notwokeshows.com, which I've delved into. Yeah, so she finds notwokeshows.com, and she's like, hallelujah, this is a goldmine, because they have listed all these criteria that they apply to define whether or not a show is woke, and whether or not they're going to include it in their recommended broadcast that one who is, let's say, not enjoying the woke agenda can safely view. I guess this is akin to the censorship board there that the BBC sponsors for you lucky members of the United Kingdom. And so you're all so fortunate that the government looks out for you so carefully and maintains your mental health in alignment with their interests. So in any case, she finds this website and it's such a rich repository of, you know, a little bit tongue in cheek, but on point. Commentary about what constitutes woke from the perspective of some group that is seeking to delineate woke from non-woke, broadcasting and being able to to list, non-woke content, that she writes to the authors and they write back and because we've become quite sensitized to issues concerning copyright. And so they write back and they say, yes, absolutely. You're free to use this. We're so grateful and all happy, happy. And so she takes basically their content and disambiguates or redacts it or restructures it so that it's not specifically about programming, but speaking more directly about what is WOKE and from the framework of these individuals that put together this website that previously has been relatively unknown and blasted out together with the crosslink to the source material, et cetera. And that's what gives rise to this fun little throwaway essay, which was her basically, uh-oh, we've got to get something out this morning. How about if we do this? while I happen to be writing an in-depth technical piece about adulteration and the RNA vaccines, which was going to take much longer. So we wanted to get something out to our Substack subscribers so they have it with their morning coffee. And that's the genesis of this particular essay. And I will finish on adulteration, another word that we've come across only in the last few days. But I love this article simply because it's what people are facing, the people are, and what you described is exactly what millions and millions of people across any country face. You look at something and you're not sure where to watch it and you're not sure what the plot line will be and often it... I've watched different shows and they start off one way, being macho with a hero, like all 24 type. And then by the end, it's something completely different. They slipped it in. They've really gotten quite clever about it in advancing this agenda of a particular way of looking at the world. And of course, the UK has been one of the world leaders in advancing nudge technology, which is what this really is, that we're encountering in broadcast media, is applied nudge. And, you know, this is another case of a slippery slope. Who's against reducing public tobacco consumption? Oh, you know, we're all for that. We don't want passive smoke. And well then, so then it's okay to use nudge to reduce that. And then, well, who's not in favour of more tolerance against ethnic minorities? Well, of course we all want that. Well, how are we gonna do it? Well, we'll take this same nudge technology and apply it like a great big hammer to that one. And so then we, I'm gonna, this is a sacred cow. So then we have the infamous Dr. Who has suddenly become a femme, et cetera. And that kind of went over like a lead balloon, as I recall. But it doesn't matter. In pursuit of the social engineering agenda, profitability and audience uptake and acceptance are totally secondary to the broader mission of advancing social equity as defined by whomever they are that established all these agendas and try to propagate it globally. Another one that I ran into recently was a CNN broadcast looking at travel and food in Italy. Who isn't interested in Italian food and travel? I mean, that's a great topic. And this is coming off of Anthony Bourdain's suicide and how successful his series was, because I think CNN is trying to pick up the ball. And so they get another actor, a well-known Italian, I'm not gonna beat him up, that tours Italy. And we're in about three episodes and suddenly we're getting propagandized about, in favour of basically Italian socialism, and the importance of accepting immigrants from North Africa and integrating them into Italian society and that these far right people, or go Giorgio Moloney, et cetera. Because anybody who is against immigration is obviously far right by definition. And Mussolini is just right there. Don't like immigration, you're one step away from full-on Mussolini fascism. And so that's how that particular series has gone. As another example is that it's become a platform for advancing these same social theories, ostensibly under the guise of a travel show focused on Italian cuisine. I mean, it pervades everything. It does, and I know that you give 15 examples. You go through, of course, The one that stands out, which you've also known for the last three years is called COVID-19 virtue signalling. Virtue signalling is a term that links with woke. But that maybe took it to a new level of advisories, COVID advisories under videos, giving you the different side. And Andrew Bridgen speaking in the House of Commons, whenever he was talking about vaccine injuries, at the bottom, it kept bringing up all these piece of information of why, what he was saying was rubbish. But even on the COVID stuff, the mask, the double, the triple masking, or people getting a sticker to say they've had a jab, it was in your face, in public, I guess, in a way that we hadn't seen before. And the social distancing, I mean, all these things had no, even though they were cloaked in scientism. Which is, you know, we've got to be careful about using that term, Jill constantly reminds me, because it is actually formally defined as, the belief system around everything that is true and real can be directly perceived and detected. So that's the essence of scientism. And in definition, it's in opposition to, let's say mysticism at one parameter and belief in theology and religion in another parameter, or we could talk about the ancient Celtic religions of paganism, for instance, all of that being in opposition to this belief that only things that we can measure and detect are true. But the term scientism has been kind of transformed a little bit with Dr. Fauci being the poster child of scientific truth is that which is asserted by largely the government and government agents that their interpretation of scientific truth is the one and only truth and there shall be no debate. And the BBC and the Trusted News Initiative have become the guarantors and the enforcers, of that logic that the only scientific truth, quote-unquote, in this post-truth, post-modern world is that which is advanced in the approved narrative endorsed by the government. And you start off, right at the beginning, it is alphabetical, but the 15th, you talk about anti-religious bias, and I'm shocked at how we see that so prevalent, that those with a belief system, and often a belief system in Christianity, are hateful or certainly hypocritical or, I mean, the level of vitriol that is attached to someone who believes something and I guess the whole issue of belief of absolutes is completely alien to a woke agenda where anything goes and truth is subjective and that level of mocking and ridiculing is dangerous certainly in a country as in yours based on biblical foundations and Christian truths and yet now we are encouraged to attack the very foundations on which our societies were based on. Right, and this is all rife with paradox. So you point out that Christianity, and in particular, traditional Christianity, and in most particular, this new insurgent movement within the Catholic Church in opposition to the Pope called Trad-Cath, those folks are in particular demonized for the sin of wanting to receive the liturgy in Latin. You can't make this up. It's so intrinsically absurd. And the bizarre paradox is that, in parallel, the prior religious orientation that was so heavily weaponized, that being radical Islam and Islam, you know, generalized Islam suddenly is aligned, in a paradoxical way with the woke slash progressive or approved agenda, in this enormous rift that has occurred in the context of, let's say gently, the IDF Gaza conflict. And I absolutely don't want to go there because I find that information landscape to be so heavily contaminated with very advanced Psy-War capabilities on both sides that once again this is absolutely a post-truth, post-modern battleground of two highly developed Psy-War capabilities going head-to-head on the world stage in which we could debate who are the victims and who are the perpetrators here, but I think truth is absolutely on the victim list. It's become completely subjective, and that's what's happened throughout all of this, is, as I keep saying, this is postmodernism, in which truth is a subjective quality that is, not intrinsic, but rather is subjective and is the product of exertion of force and capabilities in the information landscape, and is defined by those who are able to dominate that information landscape. Truth is entirely subjective and is a function of whoever is the dominant party in what I call this post-modern golden rule, those with the gold make the rules. And it's now those with the gold define truth. It's so true. We've just had today, there was Rishi Sunak, sadly, our Prime Minister here in the UK, little in substance, little in size, little in vision, but Rishi Sunak- Well, now don't be staturist. But Rishi Sunak, he was talking about a new AI Institute, which the UK is setting up, and it's going to be the world's first AI Safety Institute. And he talked about, we want to have a AI consensus on what's good and bad, just like we have a climate change census. Right, so AI has been sold to the public as a neutral arbiter of truth, but we know from the various AI applications and algorithms that are available now. That AI and machine learning and deep learning are very much a consequence, a derivative, of the source information that is used to build those algorithms, that train them. And so by selecting the information, so for instance, it's just like Wikipedia. Wikipedia defines truth as basically the work product of corporate media, which is to say the Trusted News Initiative. So if it's endorsed by TNI, then it must be true. And that is what comes out in those. So it's not even, it's beyond scientific papers. It's whatever large corporate media puts out with their spin becomes the only allowed input vector for Wikipedia. And this is done, you know, when we now know that Wikipedia is being edited in real time algorithmically by our intelligence community, including your lovely MI6. And so it, you know, people still perceive wiki as a source of basically akin to the Encyclopaedia Britannica, but it's absolutely not. Now, I haven't dove into how badly Encyclopaedia Britannica is being manipulated. I don't know the answer to that now. But the AI-based engines have absolutely been shown to have political biases that are, you know, apparently derived from their training source material. And so, for instance, the other day, Steve Kirsch gave an inquiry to one of them, that I was not familiar with previously and asked if anybody, that had been a anti-vaxxer had turned to being in favour of the vaccines. And he was very comforted by the fact that he was not so identified. But myself and Jessica Rose, and there was another person, were identified as having previously been anti-vaxxers. I'm the vaccine developer anti-vaxxer who invented RNA vaccine technology. That, you know, you have to, this is for, you know, park your cognitive dissonance is irrelevant. But then had now strongly endorsed the COVID vaccines, and indicated that everybody should get them. Absolute lie, absolute propaganda, none of that true that was listed, but that's what spat out in response to that question. And with Jessica Rose, it asserted that she was a former beauty queen. I've never heard her talk about that before. I got to ask her about whether or not she was once a beauty queen. And also went into the same kind of a flip-flop, which I know has not happened. So it's, those of us, and this is another part of my background that most people are unaware. For the first two years of my undergraduate, I was a computer science student and actually took top honours for that time. I just didn't wanna spend the rest of my life in a basement looking at a CRT tube. I was taught early on, garbage in, garbage out. With any program-based algorithm that abstracts from data, your source data will determine the product. You can have the most sophisticated deep learning algorithm, but if it is employing a biased data set, it will give you a biased answer. And that's absolutely what's happening, but it's being pitched to the public as if this is a godlike, neutral arbiter of truth, and it is so easily manipulated. The question is, is Rishi in the cohort of... I don't really understand the technology, but it seems awfully cool. And this tension always exists between nefarious intent and incompetence. And is he merely an incompetent or is he aware of how readily artificial intelligence algorithms can be manipulated? I don't know the answer to that. The dangerous thing is, I think he is aware, because I think his wife's family made the money off tech industry, partially through tech, so he should be aware of it. Exactly. He should be a sophisticated user, and then the derivative of that would be, this is not a guy that can be trusted because he's misrepresenting truth to the British public. I know that you would probably be shocked and we will probably be de-platformed and severely, maybe I better be careful because I want to fly back into London to help out Andrew on December 4th, so I don't want to get arrested when I land at Heathrow. Well, we'll see how that happens. You may just stay in the UK for a while and that will keep you. Government hospitality. You started by talking about that Netflix series, the slipping in of man love, as you said, and I've been watching another BBC programme and three series in, oh, suddenly now there's the other side, woman love and that slipped in, doesn't fit with the story, doesn't add to it at all. But in your article, you talk about bad masculinity and where male behaviour is inherently toxic and negative. But then again, the fun side, because you have to sit back and with a smile and begin to mock the chaos and confusion and people trying to jump through hoops and put these together. You've got the whole infinite genders and how that works. And I was sitting watching GB News yesterday and they had someone on who I think was, I'm not sure whether male or female, a strange hybrid. They were talking about- What's wrong with you? It's irrelevant. I no longer know what it means a trans woman. A trans woman, I think, okay, just go back to basics. How did the person start? That's where I need to start with. But this confusion, if male psychic or identification is toxic, then what happens if a woman then decides she's a man, is that then still toxic or is that now acceptable? And this chaos and confusion. Yes. Oh, like I said, the cognitive dissonance associated with this, which has no well-structured underlying logic, is profound. And so you have, like with any cognitive dissonance, you have to just park that, don't confront it, because it will drive you mad. It's, cognitive dissonance is one of the major sources of psychological pain, and, but only if you confront it. And so for your mental health, you should, Peter, you should really need to stop thinking about things like that. And, go back and and reread 1984, but consider it to be a guidance document rather than a warning document, and it will all be fine. Along those lines, I strongly, in terms of content to consider in streaming, often overlooked is this lovely little sci-fi piece with Uma Thurman, as I recall, called Gattaca. And I strongly recommend, GATTAGA is actually intended to be a DNA sequence in this particular sci-fi piece, which is very well-produced, way ahead of its time, and absolutely predicts the almost as prescient as 1984 was, absolutely predicts this new reality, postmodern reality, that we're walking into, where your genetics define, who you are and what you're allowed to be on behalf of government industry and everything else. So that absolutely should be on everybody's watch list if you haven't already seen Gattaca. But this logic that you're talking about, toxic masculinity of course, is what Jordan Peterson, has been so reviled for speaking against. And of course we all know that Jordan Peterson is now, subject to re-education by edict of his local health authority, I think in Toronto, as I recall. And they are also subjecting other physicians to what re-education processes that have had, you know, sinned by prescribing ivermectin or hydroxychloroquine for early treatment and written statements recommending that individuals should not, they should not necessarily be required to take the mRNA vaccine products or other genetic vaccine products, which the government so heavily advocates. And in those re-education processes, which the individuals are required to pay for, by the way, the state doesn't pay for that re-education. it's like three to 5,000 bucks. And at the end of which you have to write a letter demonstrating that you have successfully incorporated the teaching of the re-education process and that you are sufficiently contrite for your past sins. And if you do not show sufficient contrition in this letter, I mean, this is full on Soviet, right? If you don't show sufficient contrition, Then you will have to pay for another round of re-education ad nauseum until the overseers believe, they become convinced, that you have provided the necessary written, signed documentation that demonstrates that you are requesting humbly forgiveness for your sins, and that you have indicated clearly in this public document that you will not sin again. And so anybody that asserts that this is not actually a false religion isn't paying attention, because that's what we have, this, whatever you want to call it, wokeism or whatever, this new censorship, industrial complex, propaganda infrastructure that so much of it traces back to UK social science, I'm sorry to say, is now enforcing itself on the population using the classic totalitarian methodology. And I'm reminded, someone pointed out to me the other day when I was at Shannon Joy's event in Rochester, that Mattias Desmet, when he speaks of totalitarianism, he's not, a key differentiator between authoritarianism and totalitarianism is that authoritarianism under a dictatorship or other structure is a minority imposing its will on the population. Totalitarianism, it is the totality of society that is acting in this way. It is a social consensus, in this case a manufactured one, but it is a social consensus that this is the way we shall be. And one of the key factors in when totalitarianism emerges in a society and basically integrates itself into the entire system is that you can turn over the leadership, ergo Rishi and the prior prime minister that you guys, that brief stint that you all experienced. Forty-five days. You can replace the leadership, and it will not change the process until the entire population wakes up from what's happening. Because there will be new leaders emerge organically from the society to fill that role of dear leader. Because this is absolutely a function of a deep psychological process that is consumed the society. So we can all in our little bubble of resistance cell, Is it 20% of people? Is it 5%? We can go back and forth. We can all laugh at the sheep and what's going on and point out their logical inconsistencies. It's irrelevant until such point as people literally wake up and recognize that this is, at a minimum, not meeting their needs. You know, this is the classic question, are you better off than you were earlier on under this, I guess it's conservative government that you have that is not acting very conservative? Yeah. are you better off now than you were then? And at some point the culture says, no, we need a change. And they collectively wake up, but when that's gonna be, is it gonna be next year? Is it gonna be next decade? Or is it gonna be 100 years from now? There's no way to predict. Yeah, I'm just imagining, sorry, I'm just imagining Jordan Peterson writing a letter of apology to the Canadian government saying how wrong he was. I think this actually could be a series, you could have different, I'm sure you would love to do one program, you know, many people, a whole 45-minute fly on the wall, high-profile individuals writing I'm so sorry letters, sounds perfect. Yeah, I think Babylon Bee needs to take this up immediately. Hey, there's one more. Russell Brand ought to do this. This is absolutely made for Russell Brand. I think you need to patent this idea immediately. Russell Brand's an intriguing character. I'm not going to go there. One other thing I'd pull out, distorted racism, and this pitting people against others. Living in London, being in a very mixed culture, coming from Northern Ireland, being in a mono culture, and enjoying that mix and all that brings, and then this push to, no, you must see racism behind everything. That on top of everything else, it is, the tension that is developing in society is frightening. The people are encouraged to pit themselves against someone else instead of agreeing to disagree, not allowed to agree to disagree. And if you don't agree, you're wrong, you must be hated, you must be mocked, you must be attacked. You see as well in the States that that tension is bubbling under the surface. And it's just, I mean, we're laughing at our Canadian colleagues, but we know that they have been at the tip of the spear in advancing a lot of these agendas, most notably the de-banking, is the most egregious example. And Nigel can, there in the UK, can speak eloquently at length about the debanking agenda and its intended linkage with social credit system. Yeah, so the question is, I think for all of us, again, this grappling with the tension between incompetence and nefarious intent, which is so hard to disambiguate unless we're mind readers or we are able to get through Freedom of Information Act, the smoking gun documents that establish nefarious intent. But this division of society, again and again and again, repeated division into subgroups on top of subgroups on top of subgroups, absolutely has the appearance of serving the interests of large financial and power interests, which may be transnational, multinational, or globalist. We have these euphemisms that are all used. Just as the hypothetical, not saying necessarily this is what's happening, but if you had, let's say, traditional monarchists or large banking conglomerates. Or we can go down the list of potential actors that were interested in further enhancing their power and financial base at the expense of what ostensibly is a self-governing populace, then I hesitate to use the term democracy. And I would get attacked if I used the term democracy in the United States, because we don't technically have a democracy, just like technically you don't have a constitution. But it certainly has appeared to be in the interests of these very large concentrated power blocks that are led by a very small number of individuals who happen to be, have accumulated, you know, calling it wealth is kind of almost a misnomer, assets in power that they have, they and their families or progenitors or associates have historically exploited to further concentrate and exert their influence over world affairs. That's my attempt to be politically correct and wrap things with words that the average person would just say, well, they're all corrupt and they want to run the world. And as I get, again, I cite back the postmodern golden rule, those of us of a certain age recall when the golden rule was due unto others as you would have them do unto you. And in the postmodern world, the golden rule is those with the gold make the rules. Maybe it's always been that way. I don't know. Maybe I was just naïve back then when I was listening to my pastor speak on the lectern in the Episcopalian church that my parents used to go to. And that's another thing that I find fascinating When you think about it, we all, many people used to... I'll say, make fun of the Church of England in its leadership in advancing what we now recognize as a woke agenda. But it is increasingly normalized across much of the Christian theologic space, notably including the Catholic Church, the current pope. So maybe we got it all wrong. Maybe the Episcopalians were actually the tip of the spear in advancing the new world order. I don't know. But it kind of increasingly looks that way. One would never imagine the Episcopalian clergy as, I don't think any stereotype would label them as the avant garde cutting edge of social change. And yet, so it would seem. Yeah, that fight for truth in the church, whenever it's there in black and white in the Bible. Can we finish on, word of the week, adulteration, this, I guess, Great memes circulating, with, I guess the Sermon on the Mount with the stone tablets, with the 10 commandments and the statement, thou shalt not commit adulteration. And no, it's not adultery. Yeah, so this is a scientific technical term and a regulatory term. It's actually entrenched in American federal law and throughout the world in regulatory statutes, and policies that have largely been enforced and structured, through the International Committee on Harmonization, throwing out some buzzwords there for all of you wokes, which is kind of the international body that has harmonized it. You know, that's another good woke term, very important in European politics. We all want to be harmonized and aligned. But harmonized regulatory policies globally, so that Mr. Pharma doesn't have the inconvenience of having to restructure their regulatory documents for each nation state that they submitted to. So harmonization is important, and a key term throughout all of this is adulteration, which is in its simplest form. It is the incorporation of adulterants or impure material into, in the original American statute, food, devices, or drugs. Remember, we have the Food and Drug Administration that's responsible for this. And it goes back to the time of the scandals that Upton Sinclair revealed in his classic works, literary works, concerning the Chicago slaughterhouse environment and contamination of food with rat faeces and other materials. So rat faeces or other awful, you know, excrement from animal species contaminating foodstuffs is absolutely considered to be an adulterant. But technically in the drug space, adulteration consists of inclusion of materials in a final drug product, that are not specifically disclosed in the label. Remember the label also includes that little package insert that goes in the box that says all those things that nobody ever reads in the very fine print. But basically, as one is allowed to market a drug product, typically that requires the final drug product, I'll say this way, is defined as the sum total of everything that goes into making it. So the manufacturing process, the testing and release, the regulatory documentation, the documentation about the clinical trials, all of that, it's not just the stuff that's in the pill or in the syringe, but it's all that stuff, that documentation and information that surrounds it, that cloud of information. And so technically, if a regulatory authority together with a manufacturer disclose that, well, In fact, in our product, there is a certain fraction of rat feces, but we have a test for rat feces, and those rat feces cannot exceed 0.001% or whatever the thing is. That type of thing makes that not an adulterant. If it is disclosed and you have some parameters around it, then that's acceptable. What's happened here with these RNA genetic products is that two things have not been disclosed. And basically, they have been detected, by two different laboratory groups, one in the United States and one in the University of Guelph. You'll remember University of Guelph being the home of Byron Bridle. And so now we have another Guelph dissenter, solid, rock-solid scientist in his group that does DNA sequencing that these two groups have acquired at great difficulty because, of course, this is forbidden in most nation states to be able to analyze the vials that Pfizer or Moderna give us. We're told to just accept them that they are as they are asserted to be, which has never been the case with other drugs. Always a national authority like Paul Ehrlich or the European Union will independently verify that what is in the vial by random sampling is in fact what pharma says is in the vial. And it's within those limitation parameters that are predefined in the regulatory package. But it turns out that they were asleep at the switch or wilfully ignorant or we can extend that out, and hopefully someday we'll have the documentation to allow us to discern how the heck this happened. But we are hearing now more and more a cascade of mea culpa statements, from European Medicines Agency, Health Canada, Australian regulatory authorities, yet to hear this from the FDA for some reason, that in fact, we're guilty. We weren't aware. Mr. Pharma misled us. Pfizer, Moderna, whomever, misled us. And in fact, there is quite a bit of these small linear DNA fragments contaminating the final drug product. And by the way, the DNA source, a circular piece of DNA that was used to manufacture the RNA, it was grown in bacteria. And that leads to another whole can of worms is the endotoxin contamination. And whether it's been adequately monitored. Endotoxin being something that's known to cause shock in humans when injected, humans turn out to be exquisitely sensitive to injected endotoxin compared to many other species. And that may have something to do with some of the anaphylactic reactions that patients develop within the first 24 to 48 hours. Certainly that is consistent with endotoxin contamination. but also that we have this DNA contamination. And so, because it wasn't disclosed. And furthermore, the composition sequence of the plasmid from which these short DNA fragments are derived was not disclosed. And in particular, the existence of some sequences derived from simian virus 40 were not disclosed. And a lot of then this constitutes an indulgent. And the EMA and some of these other health agencies are now basically saying, not our fault, Pfizer didn't tell us about it. And Pfizer is coming out with statements saying, well, we didn't tell you about it because we didn't think it was important. I'm paraphrasing, but that's the essence of the argument. And it turns out this is not okay, because short linear DNA fragments that are produced by degrading these plasmids are among the most highly active DNA molecules if you want to mutate a genome, let's say, of a cell line or an experimental animal. And normally, that level of DNA contamination would be below the threshold that has historically been imposed for vaccines. So it's a chronic problem, DNA contamination in vaccines. Basically, it was a major reason why the Solvay program that I was on got killed, because they couldn't get rid of all the DNA they needed to from the cell lines that were growing the flu. That's a tangent. But it's a known problem in biologics manufacturing. And so technically, the threshold level of DNA fragments that are there are below the historic allowed DNA contamination. But it's kind of apples and oranges because with an injectable, let's say, a flu vaccine, it's not designed to be a polynucleotide delivery system. Okay, but what we have here with these RNA products, thanks to the enabling technology created at the University of British Columbia by Peter Cullis and his colleagues after decades of work, by the way, they were the ones, if anybody's going to get the Nobel Prize for the enabling technology advance, it was those guys, not the pseudouridine people, but that's another tangent. So shout out to Peter Cullis, I guess, for enabling this technology in vivo. But that tech is agnostic about whether it's DNA or RNA. And so you have the most potent non-viral delivery system ever devised by man being formulated with not only RNA, in RNA that isn't really natural RNA, it has a very, very long half-life and it's immunosuppressive if that was by design, but also with these short DNA fragments, which are known to be highly mutagenic. It hasn't been proven in these formulations, but the literature is explicit on that and abundant, that short linear DNA fragments will drive mutations in your cells in your body, if it's injected through your body. And then perhaps most worrisome, we know that these formulations, based on the Pfizer common technical document that was submitted, that's the non-clinical package to get authorization to proceed. That was kind of the last shot at doing the real toxicology, revealed that these particles have a surprisingly high affinity for ovarian tissue. Which is where germ cells reside in the form of eggs, ova, and not tested was whether or not these ova take up these particles, but certainly the ovarian tissue in general does. And then of course, we also have the recommendation that pregnant women should be receiving these products. And we know from the literature that these products cross the placenta. So they are getting into baby, and baby is in first trimester in a highly, rapidly developing embryonic environment. And so my determination is this is a true risk. It is one that will manifest in the form of somatic cell cancers, particularly lymphomas and leukaemia's, which by the way, we do happen to be seeing a surgeon inexplicably. But if you wanted to, in an experimental model, drive the development of leukaemia's and lymphomas, you could use retroviral gene therapy vectors. That's why it basically killed retroviral gene therapy was because of these side effects of leukaemia's and lymphomas because of insertional immunogenesis. And you could do it experimentally if you wanted to discover oncogenes or tumour suppressor genes, because that's how this technology was used. You could deliver, using these cool new formulations from Cullis et al, short DNA fragments, and they would absolutely disrupt the genome. And so there's the cancer risk, and there's obviously a germline foetal development mutagenesis risk. And I'm confident enough, because this was the area of molecular biology that I literally cut my teeth on originally. Mouse memory tumour virus, intentional mutagenesis, and searchable mutagenesis in order to search for oncogenes and tumour suppressor genes, under the mentorship of MD, PhD pathologist, one of the first molecular pathologists who had just finished a sabbatical with Bishop Envarmus, who got the Nobel prize for discovering oncogenes. Okay, so I know this area, the literature is clear and explicit, and I'm so confident about these observations that I'm willing to put my reputation on the line and say, this is happening at some frequency. We just don't know what the frequency is right now. Well, it's a huge topic and it's a perfect end. And I know another reason to get your Substack is you've just put an article up on this, republished a trial site news piece on this and people can delve into that. But Robert, I always appreciate your time for coming on and congratulations on having a speaker in the house. Now the Republicans can continue to use their majority for to do nothing. So well done. Oh what a bizarre world we live in. So yes, all true. I'm from Louisiana and we now have a Republican governor in Louisiana who I've known and worked with. It's been my pleasure. And the new speaker talks the talk, so let's see if he'll be able to walk the walk about all these various issues. And time will tell on that, but they are under a pretty short deadline to fund the government. And are we going to continue to see basically kick the can down the road, continuing resolution, or are we going to see the Republican marginal Republican majority in the House that ostensibly is the ones that are supposed to create the budget actually do what they have been saying they're going to do and take up all these independent budgets for funding the various public agencies, including Department of Defense Homeland Security with CISA, the intelligence community and their black budget, and all of these other weird and wonderful agencies that we have developed here in the United States that are bleeding us all dry and driving... The other day, I was reading Doug Casey's International Man, and he used the metaphor that the American government is like Wile E. Coyote in the Roadrunner series. It's already run off the edge of the cliff and it just isn't aware that it's about to plummet down to the bottom and get crushed. We are way past the danger zone in terms of our indebtedness. I don't know what's gonna happen. 100%. For the viewers and for listeners, make sure and follow Robert if you don't already on his Twitter or on GETTR, on the Substack, and lies my government told me, is a perfect Christmas present gift. So do look out for that. Do get a... Oh yeah, please. A copy. And pass out, but- I've heard it referred to as an important historic document. Oh, it is. Oh, it is. Because it was written in real time. And that could never be written today because many of the references have been getting scrubbed from the internet. Yeah. Yeah, we've seen that. Absolutely. Robert, thanks so much for coming on, sharing your latest Substack and a number of other thoughts. So thank you. Thanks, Peter. Anytime.
Welcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials.Tune in!During this episode, you will learn about;0:00:49 - ICH Introduction0:02:13 - The Significance of ICH E6 and E80:04:41 - The Global Impact of ICH 0:08:02 - The Evolution of Technology0:11:30 - Quality by Design 0:18:51 - Operational Feasibility0:21:16 - Complementary Guidance Love the show? Subscribe, Rate, Review, Like, and Share!Let's Connect!Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: info@metisconsultingservices.com
With this report from Quick Bookkeeping LLC, you can understand the importance of global accounting standardization - and position your business in the best place for success! Find out more at https://quickbookkeepingllc.com/global-accounting-standards-harmonization/ Quick Bookkeeping LLC City: New York Address: 60 W 23rd St Website https://quickbookkeepingllc.com/ Phone +1-877-675-4340 Email scott.hall@betteronlineinfo.com
Wiley's cyber team talks about cyber incident reporting after a new report from DHS advising Congress on duplication of reporting regimes. With over 50 reporting requirements spread over 20 agencies, federal agencies and the private sector should heed this report and look for ways to reduce burdens. Harmonization will be all the more challenging after the Securities and Exchange Commission (SEC) finalized controversial new reporting mandates, as DHS is developing major new reporting rules, and other agencies adopt and propose varied and different reporting requirements. Indeed, just this week, the Federal Acquisition Regulation Council dropped yet more reporting mandates for federal contractors. This podcast comes in the wake of news of a recent leak to the press of cyber attack information reported to the government by a prominent government contractor, illustrating the sensitivity of these issues. Join Megan Brown, Lyn Brown, and Josh Waldman for a discussion of the new report and what is on the horizon for cyber incident reporting.
In this week's Security Sprint, Dave and Andy talked about the following topics. Security Planning CISA: New Product - Protecting Houses of Worship: Perimeter Security Considerations Infographic. The Cybersecurity and Infrastructure Security Agency (CISA) released the Protecting Houses of Worship: Perimeter Security Considerations Infographic. CISA: Security Planning Workbook. Security Planning Workbook (PDF) DHS: This #SeeSayDay Take the Pledge to Protect Your Community If You See Something, Say Something® #SeeSayDay. Selected FB reports: Statement from President Joe Biden on Yom Kippur Synagogues brace for bomb threats, ‘swatting' attacks as Yom Kippur begins Escambia County church a 'total loss' after overnight fire Bomb Threat Forces Evacuation at Screening of John MacArthur's ‘The Essential Church' at G3 National Conference Anne Arundel police announce arrests in three hate bias cases at area churches FBI WARNED SIKHS IN THE U.S. ABOUT DEATH THREATS AFTER KILLING OF CANADIAN ACTIVIST INVITATION: Protecting Places of Worship Weeks of Action Virtual Events + DHS Resources Bomb threats target US synagogues during Rosh Hashanah West Virginia Man Admits to Obstructing Tree of Life Trial TikTok Shoplifting Threats. https://www.the-sun.com/news/9148713/retail-chains-tiktok-videos-shoplifting-warning-employees/ Jen Walker, Superstar, and Ransomware Resilience Congratulations to our 2023 SC Media Women in IT Security honorees. “Today SC Media shines a spotlight on 20 business leaders as part of our 2023 Women in IT Security program. Thank you to SC Media for recognizing Gate 15's very excellent Jennifer Lyn Walker in the 2023 Women in IT Security list‼️ Private Public Partnership. FBI Director Christopher Wray Speaks at 2023 mWISE Cybersecurity Conference. Cyberspace Solarium Commission's (CSC's) 2023 Annual Report on Implementation. Key Takeaways from the 2023 Security Summit Hosted at the Fortinet Championship. Ransomware. House Oversight Committee: Combating Ransomware Attacks MGM Resorts are operating ‘normally' after hacks, sort of TribalNet: Cyber experts wrap up MGM hack at San Diego conference. The MGM Breach and the Role of IdP in Modern Cyber Attacks TribalNet: Gaming tech exec says it's time finally to talk about cybersecurity MGM vs. Caesars: Cybersecurity Expert Rates Hacking Responses PhilHealth hit by Medusa ransomware, aims for site restoration by Monday Ransomware group claimed to have hit a New Jersey cardiology group. Did they? Growing Ransomware Threats: Looming Danger for ICS, Industrial Companies Morroco disaster scams / misinformation on social media, scams The Gate 15 Interview: Malicious Info Operations & MDM, the Space Sector, supply chain resilience, the City of Light, and nudging the world in a better direction. Misinformation research is buckling under GOP legal attacks GOP legal attacks create a chilling effect on misinformation research The Rise of Generative AI and the Coming Era of Social Media Manipulation 3.0 Quick Hits: Perspective: Homeland Security and the Shutdown Threat: Planning for an Unnecessary Contingency Alarm bells ring as lawmakers prep for possible shutdown U.S. braces for calamitous, costly government shutdown in eight days IT-ISAC: Cyber experts set out plan to secure crucial 2024 US election Health-ISAC QR Codes. https://www.aha.org/h-isac-white-reports/2023-09-19-h-isac-tlp-white-observed-increase-qr-code-phishing-attacks-september-19-2023 Harmonization of Cyber Incident Reporting to the Federal Government. El Nino winter. https://www.cnn.com/2023/09/25/weather/el-nino-winter-us-climate/index.html
Rita and Vija explore what it meant for Jacob, and for the disciples in the storm, to wrestle. How have other people struggled with their consciences, and their internal and external obstacles? How do you wrestle?Sermon begins at minute marker 8:18Genesis 32.22-30, Luke 8.22-25ResourcesAnnie Dillard's quote comes from her book Teaching a Stone to TalkQuote from Meister Eckhart: “The eye through which I see God is the same eye through which God sees me; my eye and God's eye are one eye, one seeing, one knowing, one loving.” Quote from Louise Penny in Glass Houses: She features a cobrador, a “cloaked figure acting as a conscience to those without one, forcing payment of a moral debt.”Image: VijaHymn: VT 595 When the Storms of Life Are Raging. Music and text, Charles A. Tindley. Harmonization, William Farley Smith ©1989 United Methodist Publishing House. Permission to podcast the music in this service obtained from One License with license #A-726929. All rights reserved.
With 45 different cyber incident reporting requirements in place across the federal government, and even more on the way, the Department of Homeland Security is recommending the adoption of a standard definition for a “reportable cyber incident” and a common form organizations can use to comply with the different rules. DHS today released a report on “Harmonization of Cyber Incident Reporting to the Federal Government.” The document, at more than 100 pages long, provides detailed recommendations for streamlining different incident reporting rules. “It is imperative that we streamline these requirements,” DHS Under Secretary for Policy Rob Silvers, chairman of the council, said in a statement released with the report. “Federal agencies should be able to receive the information they need without creating duplicative burdens on victim companies that need to focus on responding to incidents and taking care of their customers.” Learn more about your ad choices. Visit megaphone.fm/adchoices
With 45 different cyber incident reporting requirements in place across the federal government, and even more on the way, the Department of Homeland Security is recommending the adoption of a standard definition for a “reportable cyber incident” and a common form organizations can use to comply with the different rules.DHS today released a report on “Harmonization of Cyber Incident Reporting to the Federal Government.” The document, at more than 100 pages long, provides detailed recommendations for streamlining different incident reporting rules.“It is imperative that we streamline these requirements,” DHS Under Secretary for Policy Rob Silvers, chairman of the council, said in a statement released with the report. “Federal agencies should be able to receive the information they need without creating duplicative burdens on victim companies that need to focus on responding to incidents and taking care of their customers.” Learn more about your ad choices. Visit podcastchoices.com/adchoicesSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
#TrueNorth Podcast | IpX experts Brandy Taylor and Michael Benning explore the challenges and strategies of aligning processes across diverse divisions and products while designing them with business goals in mind, maintaining balance, and considering deviations when necessary. They highlight communication, stakeholder support, and adaptability as key factors to success and provide insights into the complexities of achieving process harmonization while emphasizing strategic problem-solving and effective communication. This episode is hosted by IpX's Deanna Hensley.Watch this episode on YouTube.This podcast was based Michael Benning's blog, "Finding and Achieving the Appropriate Level of Process Standardization."Connect with IpX to hear more industry thought leaders. Learn how IpX can help your organization evolve with our functional blueprint for the ecosystem of tomorrow. Drive innovation, create a better customer experience, and enable your workforce as an organization built for change, speed, quality and resiliency. www.IpXhq.comStay in touch with us! Follow us on social: LinkedIn, Twitter, Facebook Contact us for info on IpX or for interest in being a podcast guest: info@ipxhq.com All podcasts produced by Elevate Media Group.
Immerse yourself in a deeply relaxing and meditative experience with the soothing melodies of the Native American flute, accompanied by the tranquil sounds of a gentle waterfall and rain. This combination creates an environment that encourages relaxation, inner peace, and a heightened sense of serenity. The enchanting tones of the Native American flute carry you on a journey of tranquility, evoking a connection with nature and the spirit of ancient wisdom. The melodic and soulful melodies played on the flute resonate with your being, allowing you to release tension and find inner harmony. As the flute music weaves its way through your senses, the gentle sounds of a waterfall and rain provide a backdrop of natural serenity. The cascading water and gentle raindrops create a soothing and rhythmic ambiance, inviting a sense of calm and stillness into your space. Together, the Native American flute music, waterfall sounds, and rain create a harmonious symphony that calms the mind, eases stress, and promotes deep relaxation. It is an invitation to let go of worries, immerse yourself in the present moment, and find solace in the beauty of nature's embrace. Whether you are seeking solace, practicing meditation, or simply desiring a moment of tranquility, allow yourself to be carried away by the enchanting melodies of the Native American flute, harmonized with the peaceful sounds of a waterfall and rain. Let this immersive experience transport you to a state of deep relaxation, where you can reconnect with your inner self and find solace in the gentle embrace of nature's symphony. Relax, Meditate, Soothing, Native American flute music, Calming sounds, Waterfall, Rain, Environment, Relaxation, Inner peace, Serenity, Melodies, Connection, Nature, Ancient wisdom, Tension release, Inner harmony, Senses, Cascading water, Raindrops, Rhythmic ambiance, Calmness, Stillness, Space, Symphonic harmony, Mind calming, Stress reduction, Deep relaxation, Letting go, Present moment, Solace, Beauty, Nature's embrace, Seeking solace, Meditation practice, Tranquility, Immersive experience, Enchanting melodies, Harmonization, Peaceful sounds, Transport, Reconnect, Inner self, Gentle embrace, Nature's symphony. Support our mission of spreading relaxation and wellness by rating and reviewing our podcast on your preferred platform. Your feedback helps us improve and enables others to discover the benefits of our soothing sounds. Enhance your listening experience by subscribing to our ad-free version, immersing yourself in uninterrupted tranquility. Clicking Here Join our community of relaxation seekers and embark on a journey of self-discovery. Subscribe, rate, and review Meditation Sounds today and unlock a world of serenity and rejuvenation. Email List Support this podcast https://www.meditationsoundspodcast.com Say goodbye to stubborn belly fat with our revolutionary product! Our formula is designed to target and dissolve unwanted fat, leaving you with a slimmer, more toned midsection. Try it now and experience the results for yourself. #dissolvebellyfat #slimandtoned http://bit.ly/3jV1Ip1 Learn more about your ad choices. Visit megaphone.fm/adchoices
Unleash the power of your Root Chakra with our specially crafted music designed to unblock and energize this foundational energy center. The Root Chakra, also known as the Muladhara Chakra, is located at the base of the spine and is associated with feelings of stability, security, and grounding. Our music for the Root Chakra works to remove any blockages or imbalances that may be hindering the flow of energy in this vital energy center. By listening to this music, you can activate and harmonize your Root Chakra, allowing its energy to flow freely and bringing a sense of balance and stability to your life. The rhythmic beats and deep tones of the music resonate with the frequency of the Root Chakra, helping to ground and anchor your energy. As you listen, you may feel a sense of rootedness and connection to the Earth, allowing you to feel more grounded and centered in your daily life. This music serves as a powerful tool for healing and balancing your Root Chakra. It helps you release any fears, insecurities, or feelings of instability that may be holding you back. By unblocking and energizing your Root Chakra, you can cultivate a strong foundation for personal growth, stability, and a sense of security in your life. Allow the music to guide you on a journey of self-discovery and empowerment. As you listen, focus your attention on your Root Chakra, visualize it as a vibrant red spinning wheel of energy, and feel the music resonating with this energy center. Allow any stagnant or blocked energy to be released, making room for renewed vitality and a sense of inner strength. By regularly listening to this music and working with your Root Chakra, you can experience a greater sense of stability, security, and groundedness in all aspects of your life. Embrace the power of your Root Chakra and unlock its potential for strength, resilience, and a deep connection to the Earth. Root Chakra, Muladhara Chakra, Stability, Security, Grounding, Unblock, Energize, Energy Center, Blockages, Imbalances, Flow of Energy, Activation, Harmonization, Balance, Rhythmic Beats, Deep Tones, Frequency, Grounding, Anchoring, Connection to Earth, Rootedness, Centeredness, Healing, Personal Growth, Stability, Security, Release, Empowerment, Self-Discovery, Red Spinning Wheel, Vibrant Energy, Stagnant Energy, Renewed Vitality, Inner Strength, Regular Practice, Stability, Resilience, Connection to Earth. Support our mission of spreading relaxation and wellness by rating and reviewing our podcast on your preferred platform. Your feedback helps us improve and enables others to discover the benefits of our soothing sounds. Enhance your listening experience by subscribing to our ad-free version, immersing yourself in uninterrupted tranquility. Clicking Here Join our community of relaxation seekers and embark on a journey of self-discovery. Subscribe, rate, and review Meditation Sounds today and unlock a world of serenity and rejuvenation. Email List Support this podcast https://www.meditationsoundspodcast.com Say goodbye to stubborn belly fat with our revolutionary product! Our formula is designed to target and dissolve unwanted fat, leaving you with a slimmer, more toned midsection. Try it now and experience the results for yourself. #dissolvebellyfat #slimandtoned http://bit.ly/3jV1Ip1 Learn more about your ad choices. Visit megaphone.fm/adchoices
Pink Sheet reporters and editors discuss CMS's latest coverage announcement for Alzheimer's drugs and the VA's approach to the issue (0:29), the FDA's new one-page patient medication information document (15:55), international convergence on COVID-19 vaccine strain selection (24:48), and Novavax's place in the vaccine toolbox going forward (28:21). Read More In The Pink Sheet Medicare Registry Plan For Alzheimer's Drugs Pairs CMS Web Portal With Health System Efforts https://pink.pharmaintelligence.informa.com/PS148313/Medicare-Registry-Plan-For-Alzheimers-Drugs-Pairs-CMS-Web-Portal-With-Health-System-Efforts The US VA And Alzheimer's: A Misunderstood Decision https://pink.pharmaintelligence.informa.com/PS148214/The-US-VA-And-Alzheimers-A-Misunderstood-Decision One-Page Patient Medication Information Document Moves Forward Under Proposed Rule https://pink.pharmaintelligence.informa.com/PS148298/One-Page-Patient-Medication-Information-Document-Moves-Forward-Under-Proposed-Rule International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine https://pink.pharmaintelligence.informa.com/PS148301/International-Regulators-Focus-On-Omicron-XBB-For-Monovalent-COVID-19-Vaccine Novavax Readying Multiple COVID-19 Vaccine Candidates To Ensure Fall Availability https://pink.pharmaintelligence.informa.com/PS148261/Novavax-Readying-Multiple-COVID-19-Vaccine-Candidates-To-Ensure-Fall-Availability
Throughout the Biden administration and this Congress, spectrum has been a priority for nearly everyone else in the world—except for us. We're currently 378 megahertz behind other countries on mid-band spectrum, a vital resource for 5G communications quality. Spectrum isn't anything we can see or touch, yet it's all around us. However it is perhaps the most important infrastructure for our modern age as more and more tech communicates wirelessly. It is also a finite resource, which makes changes to its allocation exceedingly touchy. How can we navigate this pressing allocation issue within a context of selfishness and scarcity?To walk us through what is holding us back on spectrum, we have Roger Entner back on the podcast. Entner is the founder of Recon Analytics, but his vast telecommunications experience includes being the senior vice president and head of research at Nielsen Media Research.In this episode, Shane reiterates spectrum's necessity while Roger identifies the smoking gun. Tune in as they band together on the precious resource of spectrum!
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: How FDA Reviews Combination Products Industry's role in shaping policy Essential Performance Requirements IMDRF and International Harmonization Opportunities Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH's Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.
One of my favorite things about living an aligned life is the wild synchronicities that happen as a result. When we are operating in a Unified Field with our Divine nature, in service to humanity and our most beautiful trajectory... the sacred geometry of the universe makes itself known through indisputable signposts. Okay, I know I sound like a heady hippie right there. I own it. One of those synchronicities was my meeting of Ryan Seaman, today's guest on the podcast. We met about two years ago in Los Angeles through a mutual friend... and since I have a digital marketing agency, Ryan invited me into a Zoom call with his Maui-based business partner Brian, to discuss their superfood co-creation, which had yet to be named at the time. Fast-forward to today, and I'm now synchronistically living on Maui, hanging out with Brian, and eating their Superfood Pancakes with my son, Indy. On this episode, Ryan and I go DEEP AF, because Ryan doesn't know how to just talk about pancakes and nutritional health. We dive into karma, samsara, alchemy, the shadow, and the harmonizing of duality. And, of course, superfood pancakes. Ryan is an astrologer and a sci-fi writer, who also happens to have an extensive background in alternative medicine and a passion for holistic health. Like many who gravitate to the healing path, it was his own dark night of the soul that led Ryan down a very different path than his degree in business and had otherwise prepared him. Ryan is intellectual and FULL of insight. His company, Living Prana, is an outpouring of his love for the health and evolution of humanity. May his words... and pancakes... light your path... Guest Links: https://www.livingprana.co/resonate (AFFILIATE LINK - get 15% off your order) https://www.instagram.com/ryanscottseaman/ www.themedicinegate.com https://www.instagram.com/living_prana/ Host Links: https://www.instagram.com/resonatewithsara/ https://www.instagram.com/consciousconversion/ https://www.consciousconversion.com/